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Iron Absorption and Requirements in Pregnancy and Lactation (PILLAR_II)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05973552
Recruitment Status : Recruiting
First Posted : August 3, 2023
Last Update Posted : August 3, 2023
Sponsor:
Collaborators:
Columbia University
Jomo Kenyatta University of Agriculture and Technology
Msambweni County Referral Hospital
ETH Zurich
Information provided by (Responsible Party):
University of Oxford

Study Description
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Brief Summary:

Iron requirements increase significantly during pregnancy. Current recommendations for iron intake in pregnant and lactating women (PLW) are mainly based on factorial estimates and extrapolated from non-PLW. High-quality quantitative data on iron requirements in PLW are lacking, particularly in Sub- Saharan Africa where anaemia and infections are common.

The primary objective of this study is to use the stable iron isotope technique to determine iron requirements and assess iron absorption and losses in PLW living in Kenya.

In this prospective observational study, we will enrol pregnant women in the first trimester (n = 250) from a previous study cohort (n=1000) who participated in an iron absorption study at least 12 months ago and received the stable iron (Fe) isotope 57Fe. This 57Fe has now distributed and equilibrated throughout the women's body iron. Once enrolled in the present study, following Kenyan guidelines, women will receive standard prenatal care, including routine daily iron and folate supplementation. We will collect venous blood samples in each trimester and at delivery, and during the first 6 months of lactation in the mothers and infants (heel prick samples). To directly assess dietary iron absorption, in a randomly selected subset of women (n=35), oral and intravenous stable iron isotope tracers (54Fe, 58Fe) will be administered in the 2nd and 3rd trimesters.


Condition or disease Intervention/treatment
Iron Requirements Pregnancy Lactation Infancy Iron Absorption Other: CO-rebreathing Other: Oral iron isotope administration (54Fe) Other: Intravenous iron isotope administration (58Fe)

Study Design
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Layout table for study information
Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Iron Absorption and Requirements During Pregnancy and Lactation in Kenyan Women
Estimated Study Start Date : July 31, 2023
Estimated Primary Completion Date : June 30, 2026
Estimated Study Completion Date : September 1, 2026

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
All participants
Women (n=250), are followed throughout their pregnancy. Mother-infant pairs are followed throughout the first 6-months postpartum. Women receive daily oral iron supplementation during pregnancy in accordance with local standards of care. Using the stable iron isotopes dilution methodology, concentration of the stable iron isotope tracer (57Fe) in circulation will be measured throughout pregnancy and up to 6 months postpartum in both, mother and infant.
 Other: CO-rebreathing
In the CO-rebreathing method, a dedicated apparatus is used for inhaling and rebreathing a very small bolus of CO through a spirometer for ~2 min, which is absorbed through the lungs and binds to Hb, and then the increase of HbCO content of blood is measured 8 min after the CO inhalation. The increase of COHb in blood samples can then be used to precisely calculate Hb mass and blood volume
Randomly selected sub-group
To directly assess dietary iron absorption, in a randomly selected subset of women (n=35), oral and intravenous stable iron isotope tracers (54Fe, 58Fe) will be administered. Oral iron absorption and erythrocyte iron incorporation will be measured 14 days after tracer administration.
 Other: CO-rebreathing
In the CO-rebreathing method, a dedicated apparatus is used for inhaling and rebreathing a very small bolus of CO through a spirometer for ~2 min, which is absorbed through the lungs and binds to Hb, and then the increase of HbCO content of blood is measured 8 min after the CO inhalation. The increase of COHb in blood samples can then be used to precisely calculate Hb mass and blood volume

Other: Oral iron isotope administration (54Fe)
Participants randomly assigned to the sub-group, will receive 54Fe with a test meal in the second and third trimester for assessment of dietary iron absorption

Other: Intravenous iron isotope administration (58Fe)
Participants randomly assigned to the sub-group, will receive intravenous 58Fe in the second and third trimester for assessment of erythrocyte iron incorporation


Outcome Measures
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Primary Outcome Measures :
  1. Iron absorbed, lossed and gained in the first trimester [ Time Frame: Change in 57Fe tracer abundance between gestational age 6, 10 and 15 weeks ]
    isotope dilution

  2. Iron absorbed, lossed and gained in the second trimester [ Time Frame: Change in 57Fe tracer abundance between gestational age 15, 20 and 25 weeks ]
    isotope dilution

  3. Iron absorbed, lossed and gained in the third trimester [ Time Frame: Change in 57Fe tracer abundance between gestational age 25, 30 and 35 weeks ]
    isotope dilution

  4. Iron absorbed, lossed and gained throughout pregnancy [ Time Frame: Change in 57Fe tracer abundance between gestational age 6, 10, 15, 20, 25, 30 and 35 weeks ]
    isotope dilution

  5. Iron absorbed, lossed and gained in lactating women [ Time Frame: Change in 57Fe tracer abundance between 6, 14 and 24 weeks postpartum ]
    isotope dilution

  6. Iron absorbed, lossed and gained in infancy [ Time Frame: Change in 57Fe tracer abundance between age 6, 14 and 24 weeks ]
    isotope dilution


Secondary Outcome Measures :
  1. Fractional iron absorption (%) in the second trimester [ Time Frame: gestational age 20 weeks ]
    shift in iron isotopic ratios

  2. Fractional iron absorption (%) in the third trimester [ Time Frame: gestational age 30 weeks ]
    shift in iron isotopic ratios

  3. Erythrocyte iron incorporation (%) in the second trimester [ Time Frame: gestational age 20 weeks ]
    shift in iron isotopic ratios

  4. Erythrocyte iron incorporation (%) in the third trimester [ Time Frame: gestational age 30 weeks ]
    shift in iron isotopic ratios

  5. Hemoglobin concentration (g/dl) [ Time Frame: gestational age 6 weeks ]
    Hb

  6. Hemoglobin concentration (g/dl) [ Time Frame: gestational age 10 weeks ]
    Hb

  7. Hemoglobin concentration (g/dl) [ Time Frame: gestational age 15 weeks ]
    Hb

  8. Hemoglobin concentration (g/dl) [ Time Frame: gestational age 20 weeks ]
    Hb

  9. Hemoglobin concentration (g/dl) [ Time Frame: gestational age 25 weeks ]
    Hb

  10. Hemoglobin concentration (g/dl) [ Time Frame: gestational age 30 weeks ]
    Hb

  11. Hemoglobin concentration (g/dl) [ Time Frame: gestational age 36 weeks ]
    Hb

  12. Hemoglobin concentration (g/dl) [ Time Frame: 6 weeks postpartum ]
    mother

  13. Hemoglobin concentration (g/dl) [ Time Frame: age 6 weeks ]
    infant

  14. Hemoglobin concentration (g/dl) [ Time Frame: 14 weeks postpartum ]
    mother

  15. Hemoglobin concentration (g/dl) [ Time Frame: age 14 weeks ]
    infant

  16. Hemoglobin concentration (g/dl) [ Time Frame: 24 weeks postpartum ]
    mother

  17. Hemoglobin concentration (g/dl) [ Time Frame: age 24 weeks ]
    infant

  18. Mean corpuscular volume (fl) [ Time Frame: gestational age 6 weeks ]
    MCV

  19. Mean corpuscular volume (fl) [ Time Frame: gestational age 10 weeks ]
    MCV

  20. Mean corpuscular volume (fl) [ Time Frame: gestational age 20 weeks ]
    MCV

  21. Mean corpuscular volume (fl) [ Time Frame: gestational age 30 weeks ]
    MCV

  22. Mean corpuscular volume (fl) [ Time Frame: 6 weeks postpartum ]
    mother

  23. Mean corpuscular volume (fl) [ Time Frame: age 6 weeks ]
    infant

  24. Mean corpuscular volume (fl) [ Time Frame: 14 weeks postpartum ]
    mother

  25. Mean corpuscular volume (fl) [ Time Frame: age 14 weeks ]
    infant

  26. Mean corpuscular volume (fl) [ Time Frame: 24 weeks postpartum ]
    mother

  27. Mean corpuscular volume (fl) [ Time Frame: age 24 weeks ]
    infant

  28. Erythropoietin concentration (mU/ml) [ Time Frame: gestational age 10 weeks ]
    EPO

  29. Erythropoietin concentration (mU/ml) [ Time Frame: gestational age 20 weeks ]
    EPO

  30. Erythropoietin concentration (mU/ml) [ Time Frame: gestational age 30 weeks ]
    EPO

  31. Erythropoietin concentration (mU/ml) [ Time Frame: 6 weeks postpartum ]
    EPO

  32. Erythropoietin concentration (mU/ml) [ Time Frame: 14 weeks postpartum ]
    EPO

  33. Erythropoietin concentration (mU/ml) [ Time Frame: 24 weeks postpartum ]
    EPO

  34. Erythroferrone concentration (ng/ml) [ Time Frame: gestational age 10 weeks ]
    ERFE

  35. Erythroferrone concentration (ng/ml) [ Time Frame: gestational age 20 weeks ]
    ERFE

  36. Erythroferrone concentration (ng/ml) [ Time Frame: gestational age 30 weeks ]
    ERFE

  37. Erythroferrone concentration (ng/ml) [ Time Frame: 6 weeks postpartum ]
    ERFE

  38. Erythroferrone concentration (ng/ml) [ Time Frame: 14 weeks postpartum ]
    ERFE

  39. Erythroferrone concentration (ng/ml) [ Time Frame: 24 weeks postpartum ]
    ERFE

  40. Hepcidin concentration (ng/ml) [ Time Frame: gestational age 10 weeks ]
    Hep

  41. Hepcidin concentration (ng/ml) [ Time Frame: gestational age 20 weeks ]
    Hep

  42. Hepcidin concentration (ng/ml) [ Time Frame: gestational age 30 weeks ]
    Hep

  43. Hepcidin concentration (ng/ml) [ Time Frame: 6 weeks postpartum ]
    Hep

  44. Hepcidin concentration (ng/ml) [ Time Frame: 14 weeks postpartum ]
    Hep

  45. Hepcidin concentration (ng/ml) [ Time Frame: 24 weeks postpartum ]
    Hep

  46. Serum ferritin concentration (ug/l) [ Time Frame: gestational age 10 weeks ]
    SF

  47. Serum ferritin concentration (ug/l) [ Time Frame: gestational age 20 weeks ]
    SF

  48. Serum ferritin concentration (ug/l) [ Time Frame: gestational age 30 weeks ]
    SF

  49. Serum ferritin concentration (ug/l) [ Time Frame: 6 weeks postpartum ]
    mother

  50. Serum ferritin concentration (ug/l) [ Time Frame: age 6 weeks ]
    infant

  51. Serum ferritin concentration (ug/l) [ Time Frame: 14 weeks postpartum ]
    mother

  52. Serum ferritin concentration (ug/l) [ Time Frame: age 14 weeks ]
    infant

  53. Serum ferritin concentration (ug/l) [ Time Frame: 24 weeks postpartum ]
    mother

  54. Serum ferritin concentration (ug/l) [ Time Frame: age 24 weeks ]
    infant

  55. Soluble transferrin receptor concentration (ul/l) [ Time Frame: gestational age 10 weeks ]
    sTfR

  56. Soluble transferrin receptor concentration (ul/l) [ Time Frame: gestational age 20 weeks ]
    sTfR

  57. Soluble transferrin receptor concentration (ul/l) [ Time Frame: gestational age 30 weeks ]
    sTfR

  58. Soluble transferrin receptor concentration (ul/l) [ Time Frame: 6 weeks postpartum ]
    mother

  59. Soluble transferrin receptor concentration (ul/l) [ Time Frame: age 6 weeks ]
    infant

  60. Soluble transferrin receptor concentration (ul/l) [ Time Frame: 14 weeks postpartum ]
    mother

  61. Soluble transferrin receptor concentration (ul/l) [ Time Frame: age 14 weeks ]
    infant

  62. Soluble transferrin receptor concentration (ul/l) [ Time Frame: 24 weeks postpartum ]
    mother

  63. Soluble transferrin receptor concentration (ul/l) [ Time Frame: age 24 weeks ]
    infant

  64. C-reactive protein concentration (mg/l) [ Time Frame: gestational age 10 weeks ]
    CRP

  65. C-reactive protein concentration (mg/l) [ Time Frame: gestational age 20 weeks ]
    CRP

  66. C-reactive protein concentration (mg/l) [ Time Frame: gestational age 30 weeks ]
    CRP

  67. C-reactive protein concentration (mg/l) [ Time Frame: 6 weeks postpartum ]
    mother

  68. C-reactive protein concentration (mg/l) [ Time Frame: age 6 weeks ]
    infant

  69. C-reactive protein concentration (mg/l) [ Time Frame: 14 weeks postpartum ]
    mother

  70. C-reactive protein concentration (mg/l) [ Time Frame: age 14 weeks ]
    infant

  71. C-reactive protein concentration (mg/l) [ Time Frame: 24 weeks postpartum ]
    mother

  72. C-reactive protein concentration (mg/l) [ Time Frame: age 24 weeks ]
    infant

  73. alpha-glycoprotein concentration (mg/dl) [ Time Frame: gestational age 10 weeks ]
    AGP

  74. alpha-glycoprotein concentration (mg/dl) [ Time Frame: gestational age 20 weeks ]
    AGP

  75. alpha-glycoprotein concentration (mg/dl) [ Time Frame: gestational age 30 weeks ]
    AGP

  76. alpha-glycoprotein concentration (mg/dl) [ Time Frame: 6 weeks postpartum ]
    mother

  77. alpha-glycoprotein concentration (mg/dl) [ Time Frame: age 6 weeks ]
    infant

  78. alpha-glycoprotein concentration (mg/dl) [ Time Frame: 14 weeks postpartum ]
    mother

  79. alpha-glycoprotein concentration (mg/dl) [ Time Frame: age 14 weeks ]
    infant

  80. alpha-glycoprotein concentration (mg/dl) [ Time Frame: 24 weeks postpartum ]
    mother

  81. alpha-glycoprotein concentration (mg/dl) [ Time Frame: age 24 weeks ]
    infant

  82. Blood volume (l) [ Time Frame: gestational age 10 weeks ]
  83. Blood volume (l) [ Time Frame: gestational age 20 weeks ]
    BV

  84. Blood volume (l) [ Time Frame: gestational age 30 weeks ]
    BV

  85. Blood volume (l) [ Time Frame: 6 weeks postpartum ]
    BV

  86. Blood volume (l) [ Time Frame: 14 weeks postpartum ]
    BV

  87. Blood volume (l) [ Time Frame: 24 weeks postpartum ]
    BV

  88. Intestinal fatty acid binding protein [ Time Frame: gestational age 10 weeks ]
    I-FABP

  89. Intestinal fatty acid binding protein [ Time Frame: gestational age 20 weeks ]
    I-FABP

  90. Intestinal fatty acid binding protein [ Time Frame: gestational age 30 weeks ]
    I-FABP

  91. Retinol binding protein [ Time Frame: gestational age 10 weeks ]
    RBP

  92. Retinol binding protein [ Time Frame: gestational age 20 weeks ]
    RBP

  93. Retinol binding protein [ Time Frame: gestational age 30 weeks ]
    RBP

  94. soluble CD14 [ Time Frame: gestational age 10 weeks ]
    sCD14

  95. soluble CD14 [ Time Frame: gestational age 20 weeks ]
    sCD14

  96. soluble CD14 [ Time Frame: gestational age 30 weeks ]
    sCD14

  97. Insulin-like growth factor 1 [ Time Frame: gestational age 10 weeks ]
    IGF-1

  98. Insulin-like growth factor 1 [ Time Frame: gestational age 20 weeks ]
    IGF-1

  99. Insulin-like growth factor 1 [ Time Frame: gestational age 30 weeks ]
    IGF-1

  100. Fibroblast growth factor 21 [ Time Frame: gestational age 10 weeks ]
    FGF21

  101. Fibroblast growth factor 21 [ Time Frame: gestational age 20 weeks ]
    FGF21

  102. Fibroblast growth factor 21 [ Time Frame: gestational age 30 weeks ]
    FGF21


Eligibility Criteria
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Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This study will recruit 250 pregnant women in the first trimester who previously participated in a stable iron isotope study (Clinical Trial ID: NCT05266703) and received 15 mg of the stable iron isotope 57Fe as an oral dose of ferrous sulphate at least 12 months before being enrolled in this trial.
Criteria

Inclusion Criteria:

  • Providing consent to the informed consent form
  • Participation in a previous stable isotope absorption study and having received an oral dose of 15 mg 57Fe at least 12 months prior to the date of inclusion in the study
  • Positive pregnancy test and gestational age <10 weeks based on history of last menstrual period
  • Permanent residence in the study area, and not expected to leave the study site for more than 4 weeks over the following 16 months
  • Assessment of good health by professional staff at Msambweni Hospital

Exclusion Criteria:

  • Pre-pregnancy body mass index >30 kg/m2
  • Blood transfusion or intravenous iron treatment within 4 months of study start
  • Major chronic infectious disease (e.g., tuberculosis, HIV+, hepatitis)
  • Major chronic non-infectious disease (e.g., Type 1 or 2 diabetes, cancer)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05973552


Contacts
Layout table for location contacts
Contact: Nicole Stoffel, PhD +41446328393 nicole.stoffel@rdm.ox.ac.uk
Contact: Joyce Wali, BSc +254704862877 stellawali507@gmail.com

Locations
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Kenya
Msambweni Referral Hospital Recruiting
Msambweni, Kenya
Contact: Edith Mwasi, MD         
Sponsors and Collaborators
University of Oxford
Columbia University
Jomo Kenyatta University of Agriculture and Technology
Msambweni County Referral Hospital
ETH Zurich
More Information
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Layout table for additonal information
Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT05973552    
Other Study ID Numbers: PILLAR_II
First Posted: August 3, 2023    Key Record Dates
Last Update Posted: August 3, 2023
Last Verified: June 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Iron
Trace Elements
Micronutrients
Physiological Effects of Drugs